FDA 510(k) Application Details - K190585

Device Classification Name	More FDA Info for this Device
510(K) Number	K190585
Device Name	Biocode Gastrointestinal Pathogen Panel (GPP)
Applicant	Applied Biocode, Inc. 10020 Pioneer Blvd. Suite 102 Santa Fe Springs, CA 900670 US Other 510(k) Applications for this Company
Contact	Robert Di Tullio Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PCH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/06/2019
Decision Date	06/05/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review